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More Proactive Approach to Cybersecurity, Former FBI Cyber Chief Says

Medtech companies need to up its game in fighting cybersecurity threats, says former chief of FBI’s cyber operations section. If not dealt with effectively, these threats can affect the function of pacemakers or compromise the intellectual property of manufacturers developing new drugs. While the risks of cyberattacks are growing, industry response has been lackadaisical at best, according to Jerry Bessette.

Cybersecurity Safety Risk Management

Eye On The Prize: Drug Delivery Advances To Fuel Ophthalmic Drug Market

The global market for ophthalmic drugs is expected to hit $30.5bn by 2020, fueled in part by the rise in age-relate eye conditions like glaucoma, dry eye and macular degeneration. However, there is still an unmet demand for technologies that can deliver these drugs effectively and over a sustained period. This article discusses what the challenges are to developing effective ocular drug delivery systems and highlights several innovative technologies in the pipeline, designed to overcome the limitations of current ophthalmic therapies and potentially accelerate growth of the market.

Ophthalmology Market Intelligence Commercial

Singapore’s Priority-Review Scheme Goes Live

Only marketing applications submitted on or after Aug. 22 will be considered for Singapore’s new priority-review scheme for medical devices.

Review Pathway Singapore Policy & Regulation

Hindsight 20/20: Raymond Cohen

Hindsight 20/20 is a new Q&A feature where medtech industry veterans share their long experience taking diverse businesses – be they start-ups or publicly-listed entities – from strength to strength and navigating through times of crises. This first instalment shines the spotlight on Raymond Cohen, who is currently CEO of venture-backed sacral neuromodulation company Axonics Modulation Technologies, Inc. The advice he gives includes not rushing into clinical studies too soon, try to go big with the fundraising and be very cautious when tackling a complex market like the US, among other things.

Business Strategies Hindsight 2020 Medical Device

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Policy & Regulation Explore this Topic

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MDUFA IV (And More) Is Law: Trump Signs A Health-Care Bill

President Trump's eleventh-hour signature on the FDA Reauthorization Act puts into play about $1bn in device user-fee collections from industry through FY 2022, new US FDA performance goals and a range of device process enhancements and reforms supported by industry.

Policy Legislation United States

US FDA: BD Didn’t Act On Faulty Lead Test Warning

An FDA-483 released as part of an ongoing probe into Magellen’s faulty LeadCare tests found GMP and MDR violations at a BD plant where some test-tube components used with the tests were manufactured.

Medical Device Diagnostics Regulation

FDA Assembling Advisors To Discuss Pediatric HDE Products

As part of a periodic review, FDA is bringing together experts to review several products that are conditionally available for pediatric use under the agency's Humanitarian Device Exemption program.

Regulation Cardiovascular

Warning Letter Roundup & Recap – Aug. 22, 2017

US FDA did not release any device-related warning letters the week of Aug. 22.

Device Warning Letters Regulation

US FDA Updates List of Recognized Medtech Standards With 49 New Entries

The US Food and Drug Administration has included 49 new standards and made several other changes to its list of recognized medtech standards. The list is a useful reference for manufacturers, who choose to declare conformity with consensus standards to meet certain requirements for medical devices and IVDs, including to help support pre-market submissions.

Regulation US States

Exec: EU May Lose Out On More Innovation As MDR Pressure On NBs Begins To Bite

The new MDR and IVDR were drafted with highest interests of EU patients in mind, but they may yet have a devastating effect on the EU's speedy access to innovation in general, and on medtech SMEs in particular. That is the view of one Swiss medtech CEO; he also has grave concerns about the loss of EU notified bodies and the impact on manufacturers.

EU Regulation

Reasons For German Challenge To Unified Patent Court Emerge; Missing Brexit Deadline Could Prove Fatal

One of the grounds for the legal challenge to Germany’s ratification of the UPC system has a clear path to resolution but three other grounds might prove tricky. Meanwhile a newly published guide explains how to obtain, maintain and manage unitary patents.

Europe Intellectual Property

Cook Removes Indication, Pulls Sizes From Market Following Graft Recall

Cook Medical is pulling certain sizes of its Zenith Alpha thoracic endovascular graft from the market due to reports blood clots and occlusions may form inside the graft when it’s used to treat blunt traumatic aortic injury.

Medical Device Recalls

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

Quality Replay: FDA Urges Firms To Close Loop On CAPAs, Create Filters To Weed Out Poor Quality Data

From our digital archives: Applying a closed-loop approach to corrective and preventive action activities is one of the best ways to ensure device quality and gather useful data, US FDA says. Manufacturers often fail to ensure that they complete the CAPA loop, leading to corrective and preventive actions that might be open for years, or product fixes that don’t work and complicate matters further by presenting the firms with a whole new set of challenges.

Quality Control Compliance

Quality Replay: Device History Record ‘Oversights’ A Clear Path To Quality Troubles, FDA Says

From our digital archives: Manufacturers are overlooking various key elements that should be included in device history records, including up-to-date labels, dates of product manufacture and missing signatures on documents, US FDA says. Because DHRs touch virtually every part of a firm’s quality system, a flawed DHR can prompt agency investigators to dig deeper during inspections. Experts from device firms Baxter and Thoratec weigh in.

Quality Control Compliance

Q2 Recalls Snapshot: Dramatic Increase In Class I Actions; Overall Recalls Dip Slightly

The number of high-risk class I recalls ballooned 88% in the second quarter of 2017. Overall, recalls fell 3%. Check out our Q2 recalls infographic.

Recalls Quality Control

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Creo Gets Early FDA Green Light For Endoscopy Device

Surgical endoscopy specialist Creo Medical has received the nod of approval to start selling its Speedboat RS2 device and CROMA platform in the US. The FDA cleared the use of the surgical endoscopy device ahead of schedule, processing the company's 510(k) application just 49 days from submission.

Approvals Commercial Companies

Latest From Commercial

Carl Zeiss Meditec Sees Data Management Potential In Cataract Surgery

Carl Zeiss Meditec has strengthened its cataract surgical offering by acquiring an intelligent cloud-based data management platform to facilitate cataract surgery planning, management and analysis.

Ophthalmology M & A

Novacyt Full Of Eastern Promise, Following Strong H1 Sales

Cervical cancer screening firm Novacyt is aiming to broaden its market penetration in Asia-Pacific by identifying strategic acquisitions. The Anglo-French firm posted strong sales growth of 40% for the first six months of 2017, with APAC representing the group's fastest growing region.

Cancer In Vitro Diagnostics

India Strikes Pricing Blow To Knees After Stent Cuts

Six months after imposing stiff price controls on cardiac stents, India’s government slashed costs of knee implants by nearly 70%, saying the action was necessary to end “unethical profiteering.”

Orthopedics India

UK Viewpoint: AHSNs, AAR And Accelerators – Market Access & Innovation Update

Dr Charlie Davie, managing director of UCLPartners, a London-based Academic Health Science Partnership and one of the 15 UK Academic Health Science Networks, updates Medtech Insight on key changes in NHS market access policy this summer.

United Kingdom Market Access

Could CMS Changes To Bundled Pay Models Stifle Medtechs' Value-Based Pay Plans?

The US Center for Medicare and Medicaid Services proposed downsizing its CJR joint replacement value-based payment model and outright canceling its cardiac procedure bundled payment model. Will the move discourage companies like Zimmer Biomet, Johnson & Johnson, and Medtronic, which have already invested in programs based on the value-based models?

Reimbursement Market Access

President Trump Disbands Business Advisory Councils

J&J and GE were among firms represented on the Trump administration's manufacturing council, one of two business advisory groups that were dissolved on Aug. 16 after a growing number of executives walked away from the endeavors in the wake of Trump's remarks regarding white nationalist demonstrations in Virginia.

Commercial United States

Clinical R&D Explore this Topic

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Siemens Unveils First 7-Tesla MRI Scanner For The Clinic

The company claims the images created by Magn etom Terra reveal fine details in anatomy and function that will help usher in the next era of precision medicine. The new system has earned a CE mark while a 510(k) is pending.

Research and Development Strategies Innovation Approvals

Latest From Research & Development

Start-Up Spotlight: Cerebrotech Hopes To Launch Portable Stroke Test Device In 2018

Results of the VITAL trial show Cerebrotech's non-invasive portable VIPS technology can distinguish patients with large-vessel occlusion strokes and large hemorrhagic strokes versus less-urgent strokes. The company hopes emergency responders will use its unique diagnostic visor to shorten the time it takes for patients suffering major strokes to get to a hospital that has the facilities to treat the stroke effectively.

Neurology StartUps and SMEs

Another Study Casts Doubt Over Off-Pump CABG Benefits

Five-year mortality and major morbidity results from a large randomized trial run by the Veterans Affairs found no advantages to so-called off-pump "beating heart" coronary bypass graft surgery over traditional on-pump bypass surgery in which the patient is supported by a cardiopulmonary bypass machine.

Cardiology Surgery

Start-Up Spotlight: LimFlow, Endovascular Treatment For End-Stage Critical Limb Ischemia

French start-up LimFlow is developing a percutaneous deep vein arterialization system, designed for installing a stent-graft that shunts blood from a diseased tibial artery into a tibial vein to revascularize the foot of a patient with severe peripheral artery disease.

Diabetic Care Wound Management

OUS Approvals: Cardiovascular Devices Lead Modest List In July

July 2017 brought 26 approvals from outside the United States, including 14 CE marks in Europe and 12 from five other territories. Almost half of the approvals were for cardiovascular devices; the rest came from eight other categories.

Approvals Innovation

Abbott Launches Feasibility Trial Of Tricuspid Version Of MitraClip

The TRILUMINATE trial will evaluate safety and effectiveness of its Tricuspid Valve Repair System for treating symptomatic moderate-to-severe tricuspid regurgitation. The device is similar to Abbott's successful MitraClip catheter-based device for treating mitral regurgitation.

Clinical Trials Innovation

US Approvals Analysis: Drug-Coated Balloon, Valve Tech Are July Highlights

July was a relatively light month for novel-device approvals by US FDA, but year-to-date volumes remain strong. Spotlighted devices include approval of a new drug-coated balloon and heart valve devices. Here's a roundup from Medtech Insight's Approval Tracker.

Approvals Innovation